W-PPMA for Postpartum Mothers

A Randomized Controlled Trial of the Feasibility and Acceptability of W-PPMA for Postpartum Mothers

To evaluate the feasibility and acceptability of W-PPMA among a diverse group of postpartum mothers.

Study Overview

• Status: Terminated
• Conditions: Postpartum Period
• Intervention / Treatment: Device: W-PPMA

Detailed Description

This randomized waitlist-controlled trial evaluates the feasibility and acceptability of the W-PPMA digital health tool.

Participants will be recruited from the IRB-approved PowerMom research study of Scripps Research and, if interested, will complete screening for the sub-study. Eligible participants will be asked to provide informed consent and complete the baseline assessments. Those that do not meet eligibility criteria may resume their PowerMom experience.

Eligible participants will be randomized to one of two groups, W-PPMA or Waitlist, and will receive instructions on when and how they can access the digital health tool. Primary endpoints will be measured at 8-weeks (end of treatment) with additional measures being collected at 1- 4-, 8-, 12-, and 16-weeks (end of study). Screening, consenting, and outcome measures will be completed online through the MyDataHelps app.

• Study Type: Interventional
• Enrollment (Actual): 281
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Ariniello, BS; Email: laurena@scripps.edu
• Study Contact Backup: Name: Lase Ajayi, MD; Phone Number: 858-554-5734; Email: tajayi@scripps.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Translational Science Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≥ 16 years of age
• Be ≤ 3 month postpartum
• Currently enrolled in Scripps Research PowerMom study
• Own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), that can receive SMS messages, and has reliable Wi-Fi access or sufficient data to engage with assigned treatment condition for the duration of the study
• Available and committed to engage with the program and complete assessments for a 16-week duration.
• Ability to read and understand English

Exclusion Criteria:

• Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
• Lifetime diagnosis of bipolar disorder
• Current suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months
• History of (a) drug and/or alcohol abuse within the past 12 months
• Fetal demise within the past 18 months
• Previous use of the Woebot app

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: W-PPMA; Participants randomized to this arm will have access to the W-PPMA mobile app throughout the 16-week study. Participants are asked to use the app for at least 5 minutes a day during the treatment phase (first 8 weeks) and then as often as they like during the follow-up phase (last 8 weeks) of the study.	Device: W-PPMA; W-PPMA is a digital health tool designed specifically for the postpartum experience and is accessed through a mobile application which delivers evidence-based therapy through brief "conversations" with a fully automated relational agent called Woebot.
No Intervention: Waitlist; Participants assigned to this group will not have access to the W-PPMA mobile app during the treatment phase (first 8 weeks) of the study. They will have access during the follow-up phase (last 8 weeks) of the study and will be instructed to use the app for at least 5 minutes a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage Rating Profile Intervention (URPI)-Feasibility	Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility.	End of Treatment (8 weeks from baseline)
Usage Rating Profile Intervention (URPI)-Acceptability	Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.	End of Treatment (8 weeks from baseline)
Client Satisfaction Questionnaire (CSQ-8)	An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale (1 = "very dissatisfied" to 4 = "very satisfied"). Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-PPMA mobile application.	End of Treatment (8 weeks from baseline)
Number of active days in the W-PPMA application	Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization.	Throughout treatment (from baseline to end of treatment at 8 weeks)
Number of messages sent per week in the W-PPMA application	Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization.	Throughout treatment (from baseline to end of treatment at 8 weeks)
Number of modules completed in the W-PPMA application	Application engagement in the number of modules completed within the application will be collected during the study to provide quantitative data regarding application content engagement.	Throughout treatment (from baseline to end of treatment at 8 weeks)
Content satisfaction ratings in the W-PPMA application	Application content satisfaction ratings will be collected during the study to provide quantitative data regarding application content engagement.	Throughout treatment (from baseline to end of treatment at 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-8)	An 8-item abbreviated version of the PHQ-9 used to assess mood and anxiety symptoms respectively. The PHQ-8 excludes an item assessing suicidality. Total score between 0-27, where higher scores indicate greater levels of depression.	Change from Baseline to End of Treatment at 8 weeks)
Edinburgh Prenatal Depression Scale (EPDS)	A 10-item self-report questionnaire used as a screening tool to identify patients who are at risk for perinatal depression. The scale assesses depression criteria including anhedonia, worry, and sleep disturbance, in the past seven days. Each item has four ordinal response options, yielding a total score of 0 to 30 such that higher scores indicate more severe symptoms.	Change from Baseline to End of Treatment at 8 weeks
Generalized Anxiety Disorder Questionnaire (GAD-7)	A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.	Change from Baseline to End of Treatment at 8 weeks
Perceived Stress Scale (PSS-10)	A 10-item self-reported questionnaire designed to measure the degree to which situations in one's life are appraised as stressful. Items comprising the PSS-10 assess the frequency of experiencing certain thoughts and feelings (e.g., feelings of upset, nervousness, a lack of control) over the past month. Each item is scored on a 5-point Likert scale from 0 (never) to 4 (very often); four positively stated items are reverse scored before summing all items to obtain the total score. Higher PSS scores indicate greater perceived stress.	Change from Baseline to End of Treatment at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mother Infant Bonding Scale (MIBS)	The MIBS consists of 8 one-word items describing an emotional response, such as ''loving'', "resentful", and ''disappointed" and is designed to assess the feelings of a mother toward her new baby. Mothers rate the degree to which they feel each of the 8 emotional responses toward their infant using a 4-point Likert scale from very much (0) to not at all (3). Five items describe negative emotional responses and are reverse scored. Total scores can range from 0 to 24, with lower scores indicating better bonding.	Change from Baseline to End of Treatment at 8 weeks
Working Alliance Inventory (WAI-SR)	A validated 12-item instrument that measures therapeutic alliance. The instrument consists of a composite score and three subscales assessing key aspects of the therapeutic alliance: 1) agreement between the client and therapist on the tasks of therapy (e.g., "As a result of these sessions I am clearer as to how I might be able to change"); 2) agreement between the client and therapist on the goals of therapy (e.g., "Woebot and I collaborate on setting goals for my therapy"), and 3) the development and strength of an affective bond between the client and therapist (e.g., "Woebot and I respect each other"). The WAI-SR will be tailored to the current intervention, replacing the term "therapist" with "Woebot".	Day 3 and End of Treatment at 8 weeks
Feasibility, acceptability, perceptions of stigma as a barrier to mental health care, and mood outcomes across key sociodemographic variables of race and ethnicity, age, and level of education	Named outcome measures will be descriptively characterized and results will be stratified according to race and ethnicity, age group, and level of education.	Baseline, Day 3 and End of Treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Woebot Health
• Collaborators: Scripps Translational Science Institute
• Investigators: Principal Investigator: Lase Ajayi, MD, Scripps Research Translational Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Actual): January 18, 2024
• Study Completion (Actual): March 17, 2024

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: W-PPD-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No